Welcome to our dedicated page for Xeris Biopharma Holdings news (Ticker: XERS), a resource for investors and traders seeking the latest updates and insights on Xeris Biopharma Holdings stock.
Overview
Xeris Biopharma Holdings Inc (XERS) is a biopharmaceutical company that specializes in developing and commercializing innovative, ready-to-use biotherapeutics. The company is distinguished by its deep expertise in formulation science and biotherapeutic development, with a unique focus on addressing challenging conditions in the fields of endocrinology, neurology, and gastroenterology. By leveraging proprietary technologies such as XeriSol and XeriJect, Xeris aims to simplify treatment administration and improve patient outcomes through ultra-low volume injectable devices and patient-friendly formulations.
Core Technologies and Product Portfolio
Central to Xeris Biopharma’s mission is the use of breakthrough formulation science. The company’s proprietary technologies have been instrumental in creating products that stand out for their ease of use and direct applicability to clinical needs. XeriSol focuses on innovative formulation strategies while XeriJect has paved the way for ultra-low volume injectable devices that potentially mitigate the discomfort of traditional injection methods. This technological edge supports a portfolio that is uniquely positioned to serve patient populations requiring precise, efficient, and less invasive therapeutic solutions.
Commercial Products
Xeris has successfully brought several therapies to market that address critical conditions with new methods of administration. The product Gvoke offers ready-to-use liquid glucagon, designed for the rapid treatment of severe hypoglycemia, thereby ensuring swift and reliable relief during emergencies. Keveyis, another milestone, is recognized as the first FDA-approved therapy intended for primary periodic paralysis, marking a significant advancement in neuromuscular treatment options. Additionally, Recorlev provides an FDA-approved treatment for endogenous hypercortisolemia in adults with Cushing's Syndrome. Each of these commercial products not only meets specific therapeutic needs but also exemplifies the company’s commitment to refining drug delivery through advanced biotherapeutic formulations.
Innovative Pipeline and Formulation Science
Beyond its existing market offerings, Xeris Biopharma has a robust pipeline of development programs aimed at expanding its footprint in the biotherapeutic landscape. The company’s ongoing research utilizes its own formulation platforms to address unmet clinical needs. By continuously focusing on innovation in drug formulation and injectable delivery, Xeris demonstrates an unwavering commitment to pushing the boundaries of conventional treatment methodologies. Its efforts in refining ultra-low volume, ready-to-use biotherapeutics provide a strategic advantage, potentially alleviating the challenges associated with traditional injection therapies for hundreds of millions of patients.
Market Position and Competitive Landscape
Operating within the competitive arena of biopharmaceuticals, Xeris Biopharma holds a distinct niche due to its focus on patient-friendly, ready-to-use biotherapeutics. Its targeted approach in addressing conditions related to endocrinology, neurology, and gastroenterology distinguishes it from more traditional pharmaceutical companies. Positioned in a sector that demands constant innovation and a careful balance of safety and efficacy, Xeris has integrated rigorous formulation science with practical clinical applications, thus reinforcing its reputation as a company grounded in deep technical expertise and clinical insight.
Patient-Centric Approach and Value Proposition
The company’s innovative approach is underscored by its commitment to enhancing the treatment experience for patients. By developing therapies that are not only clinically effective but also easier to administer, Xeris focuses on lowering the barriers to treatment adherence. The incorporation of patient-friendly injectable devices, designed to ease the discomfort commonly associated with injections, speaks to a broader vision of improved quality of life. This patient-centric perspective is woven into every facet of the company’s operations, ensuring that every product is developed with the end-user’s comfort and convenience in mind.
Operational Excellence and Regulatory Rigor
Xeris Biopharma operates in an environment where compliance and clinical precision are paramount. The company’s products have undergone and continue to meet stringent regulatory standards, assuring stakeholders of both safety and efficacy. Through a disciplined regulatory strategy and a commitment to high-quality manufacturing practices, Xeris reinforces its position as a trusted entity in the formulation and delivery of biotherapeutics. This adherence to strict quality control further enhances the reliability of its products, establishing a strong foundation for long-term credibility in an increasingly competitive field.
Conclusion
In summary, Xeris Biopharma Holdings Inc presents a compelling case study in the integration of advanced formulation science with practical biotherapeutic applications. Its commercial products, such as Gvoke, Keveyis, and Recorlev, exemplify its ability to address diverse patient needs effectively. Supported by proprietary technologies like XeriSol and XeriJect, the company’s approach highlights a strategic blend of innovation, patient focus, and operational rigor. Through its commitment to developing ultra-low volume, ready-to-use therapies, Xeris continues to enhance treatment options within endocrinology, neurology, and gastroenterology, providing a clear reflection of expertise and a steadfast commitment to improved patient outcomes.
Xeris Biopharma reported record Q3 2024 total revenue of $54.3M, with product revenue reaching $52.9M, marking a 27% increase year-over-year and 14% quarter-over-quarter growth. Gvoke revenue grew 29% to $22.9M, while Recorlev revenue surged 119% to $17.7M. However, Keveyis revenue declined 23% to $12.2M. The company raised its full-year revenue guidance to $198M-$202M and ended Q3 with $69.4M in cash. Net loss for Q3 was $15.7M or ($0.11) per share.
Xeris Biopharma Holdings (Nasdaq: XERS) has scheduled the release of its third quarter 2024 financial results before U.S. market opening on November 8, 2024. Management will host a conference call and webcast at 8:30 a.m. ET. The company, focused on developing innovative therapies, currently markets three products: Gvoke® for severe hypoglycemia, Keveyis® for primary periodic paralysis, and Recorlev® for endogenous Cushing's syndrome.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) has announced the granting of restricted stock units (RSUs) to 42 new employees under its Inducement Equity Plan. The Compensation Committee of Xeris' Board of Directors approved the grant on October 1, 2024, for an aggregate of 364,000 shares of common stock.
These RSUs are designed as an inducement for new hires, in compliance with NASDAQ Listing Rule 5635(c)(4). The grants will vest over three years in equal annual installments, contingent on continued employment with Xeris or its subsidiaries. All awards are subject to the terms and conditions of Xeris' Inducement Equity Plan and relevant award agreements.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) has announced its participation in three upcoming investor conferences in September 2024. The company will attend the 2024 Wells Fargo Healthcare Conference in Boston on September 4 for meetings only. At the H.C. Wainwright 26th Annual Global Investor Conference in New York on September 10, Xeris will participate in meetings and a fireside chat at 3:30pm ET. Lastly, the company will be present at the 2024 Cantor Global Healthcare Conference in New York on September 18 for meetings only.
Investors interested in 1x1 meetings should contact the conference sponsors directly. A webcast of the fireside chat will be available on Xeris' investor relations website. This participation in multiple conferences demonstrates Xeris' commitment to engaging with investors and showcasing its growth-oriented biopharmaceutical business.
Xeris Biopharma (Nasdaq: XERS) reported strong Q2 2024 financial results, with total revenue of $48.1M, including record product revenue of $46.5M. This represents an 18% increase over the prior quarter and a 26% increase year-over-year. The company tightened its full-year 2024 guidance, projecting total net revenue of $190M-$200M and a year-end cash balance of $60M-$75M.
Key highlights include:
- Gvoke revenue up 28% to $20.0M
- Recorlev revenue up 86% to $13.3M
- Keveyis revenue down 7% to $13.1M due to generic competition
- Cash position of $77.6M as of June 30, 2024
- Net loss of $15.0M for Q2 2024
The company also announced leadership changes, with John Shannon appointed as CEO and Kevin McCulloch promoted to President and COO.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) has announced that it will release its second quarter 2023 financial results on Thursday, August 8, 2024, before the U.S. financial markets open. The company will host a conference call and webcast at 8:30 a.m. Eastern Time on the same day to discuss its financial and operational results.
Interested parties can pre-register for the call using the provided link. A replay of the conference call will be available until Thursday, August 22, 2024. The webcast can be accessed through the 'Events' section on the company's investor relations page or via the provided link.
Xeris Biopharma has announced a CEO succession plan effective August 1, 2024. John Shannon, the company's current President and COO, will succeed Paul Edick as CEO and join the Board of Directors. Edick will continue in a senior advisory role until February 1, 2026. Marla S. Persky will become the new Chairperson of the Board.
The timing aligns with Xeris' strong financial performance, including anticipated Q2 2024 revenue exceeding $47 million, marking over 23% growth from the previous year. The company reaffirms its year-end 2024 cash guidance to be between $55 million and $75 million. Shannon brings over 40 years of experience in the pharmaceutical and healthcare industry to his new role.
Xeris Biopharma Holdings (Nasdaq: XERS) announced the granting of restricted stock units (RSUs) for 196,000 shares of its common stock to 26 new employees. These grants, under the NASDAQ Rule 5635(c)(4), were made on July 1, 2024, as part of Xeris' Inducement Equity Plan. The RSUs will vest over three years, contingent on continued employment. This plan aims to attract new talent to the organization.
Xeris Biopharma Holdings (Nasdaq: XERS) presented a post-hoc analysis from the SONICS study at ENDO 2024 in Boston (June 1-4, 2024). The analysis focused on the effects of levoketoconazole (Recorlev®) in Cushing’s syndrome patients. Key findings include a higher cortisol normalization rate in patients with lower baseline mUFC, who also required lower doses of Recorlev and experienced fewer liver-related adverse events. Group 2, with intermediate baseline mUFC, showed the highest mUFC response rate (36.4%), while Group 3 had the highest average daily dose and more liver-related adverse events. These findings highlight the importance of individualizing medical management based on baseline mUFC levels.
Xeris Biopharma announced positive topline results from its Phase 2 study of XP-8121, a once-weekly subcutaneous levothyroxine (SC) formulation. The study showed that XP-8121 provides predictable bioavailability and sustained levothyroxine levels, achieving normalized TSH/T4 levels with 45% less drug than daily oral doses. Participants reported higher satisfaction and a strong preference for the SC route. The FDA End-of-Phase 2 interaction is expected by year-end, aiming for a Phase 3 pivotal study. Adverse events were mostly mild, with no serious adverse events reported.
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